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Tag Archives: FDA

Liberty means something, and we ought to cheer every new law that strikes against the over reach of government! H’T Conservative Hideout

When Minnesota State Representative Nick Zerwas was 15 years old, he was told he had only months to live. Informed that he wouldn’t be able to get a heart transplant, Zerwas was told by his doctor that he might be saved by a surgical procedure that was still experimental. Said Zerwas: “That was my right to try. I fully believe life is worth fighting for, and government has no role in getting in the way.”

On May 1 Zerwas’ bill, the Minnesota Right to Try Act, passed the state house unanimously, 123-0. It had previously passed the state senate, 60-4, on April 21, and on May 5, Minnesota Governor Mark Dayton signed it into law.

In general the Food and Drug Administration(FDA) prohibits access by patients to experimental drugs, but under its “expanded access” provision, the FDA allows patients with serious or life-threatening diseases access to them, but only with its express prior approval. Minnesota effectively nullified the FDA’s rule and allows Minnesotans direct access to manufacturers with such drugs

Good, it is a victory, and no, Minnesota is not alone

Minnesota is the 16th state to nullify this FDA rule, while more than 20 other states are considering similar measures. In announcing the modest victory of state’s rights over federal overreach, the Tenth Amendment Center said:Although these laws only address one small aspect of FDA regulation, they provide us with a clear model demonstrating how to nullify federal statutes that violate the Constitution.

Lots more at the link, please go read it all. the Left, of course, loathes nullification, and smears anyone who defends it, but if was good enough for Madison and Jefferson……..

Like this:

With America’s “fiscal cliff” approaching, pundits wring their hands over the supposed catastrophe that government spending cuts will bring. A scare newsletter called “Food Poisoning Bulletin” warns that if government reduces food inspections, “food will be less safe… (because) marginal companies… (will) cut corners.”

We’re going to die!

Most people believe that without government meat inspection, food would be filthy. We read “The Jungle,” Upton Sinclair’s depiction of the meatpacking business, and assume that the FDA and the Food Safety and Inspection Service are all that stand between us and E. coli. Meatpacking conditions were disgusting. Government intervened. Now, we’re safe! A happy ending to a story of callous greed.

The scheming lawyers behind the “Food Poisoning Bulletin” argue that without regulation companies will “cut corners.” After all, they say, sanitation costs money, so lack of regulation “creates a competitive disadvantage for companies that want to produce quality products.”

But that’s bunk. It’s not government that keeps E. coli to a minimum. It’s competition. Tyson Foods, Perdue and McDonald’s have brands to maintain – and customers to lose. Ask Jack in the Box. It lost millions after a food-poisoning scandal.

Fear of getting a bad reputation makes food producers even more careful than government requires. Since the Eisenhower administration, our stodgy government has paid an army of union inspectors to eyeball chickens in every single processing plant. But bacteria are invisible!

Fortunately, food producers run much more sophisticated tests on their own. One employs 2,000 more safety inspectors than government requires: “To kill pathogens, beef carcasses are treated with rinses and a 185-degree steam vacuum,” an executive told me. She also asked that I not reveal the name of her company – it fears retaliation from regulators.

“Production facilities are checked for sanitation with microbiological testing. If anything is detected… we re-clean the equipment… Equipment is routinely taken completely apart to be swab-tested.”

None of that is required by government. Government regulation may help a little, but we are safe mostly because of competitive markets.

Competition protects us better than politicians.

But people don’t trust companies. So it is easy to scare people about food. And the news media know that finding “problems” makes reporters look like crusading journalists. Earlier this year, my old employer, ABC News, “alerted” the public to a new threat, ground beef made with “pink slime.”

It sounds awful! ABC’s reporting frightened most school systems so much that they stopped using that form of meat. The food company lost 80 percent of its business.

But the scare is bunk. What ABC calls “pink slime” is just as appetizing as other food.

“Bunk is the polite word,” Dan Gainor of the Media Research Center says. “ABC went on a crusade. Three nights in a row back in March, they pounded on this.”

“A couple activists who used to work for the FDA didn’t like this really cool scientific process that separates the beef trimming so you get the remaining ground beef. So they coined this term deliberately to try to hurt this company.”

The company, Beef Products Inc., does something unique. It takes the last bit of trim meat off the bone by heating it slightly. That saves money and arguably helps the environment – not using that meat would waste 5,000 cows a day. In 20 years, there is no record of anybody being hurt by what ABC and its activists call “pink slime” – what the industry just calls “lean beef trimmings” or “finely textured beef.”

“Everybody constantly says, ‘You should eat leaner beef.’ So when we try to eat the leaner beef, then they take that away from us, too,” Gainor said. “The company… has received awards for how good a job they do for consumer safety. It was just one constant hit job.”

An effective one. After ABC’s reports, Beef Products Inc. closed three out of its four plants. Seven hundred workers lost jobs.

During Tuesday’s second presidential debate, President Barack Obama said that women “rely” on Planned Parenthood for mammograms, but, according to the Food and Drug Administration, no Planned Parenthood facility in the United States is licensed to do mammograms.

During Tuesday night’s debate against his Republican challenger Mitt Romney, Obama said, “When Gov. Romney says that we should eliminate funding for Planned Parenthood, there are millions of women all across the country who rely on Planned Parenthood for not just contraceptive care; they rely on it for mammograms, for cervical cancer screenings. That’s a pocketbook issue for women and families all across the country, and it makes a difference in terms of how well and effectively women are able to work.”

Last June, the Department of Health and Human Services said in response to a Freedom of Information Act (FOIA) request that no Planned Parenthood clinic in the United States has mammogram equipment.

The Alliance Defense Fund asked in an April 2 FOIA request to the Food and Drug Administration (FDA) for “All currently active certificates to operate a mammography facility issued by the FDA or by any state or entity designated to provide such certificates by the FDA for Planned Parenthood Federation of America, any affiliate of Planned Parenthood Federation of America or any entity whose name included ‘Planned Parenthood.’”

The HHS responded in a letter on June 4 that said, “In your request you asked for the following, all currently active certificates to operate a mammography facility for Planned Parenthood. In response to your information request, we have performed a thorough and diligent investigation of our records and there are no adverse events for these firms. Unfortunately our search did not uncover any documents pertinent to your request.”

The FDA licenses mammography centers to own and operate mammogram machines. If a facility owns or operates a mammogram machine without a government license, it could result in a $10,000 fine, according to Live Action, a pro-life group. The Alliance Defense Fund made the FOIA request in reference to the licenses.

Live Action, on a related note, conducted a similar investigation by calling Planned Parenthood clinics around the United States trying to schedule mammograms. They were told by the clinics that they did not do mammograms but could be referred to a separate, non-Planned Parenthood facility.

“When you repeatedly hear pro-Planned Parenthood, pro-abortion politicians, whether it’s [Vice President] Biden or President Obama or Planned Parenthood executives pushing this lie [about mammograms], it’s because this is their whole case for the public to justify taxpayer funding,” Lila Rose, founder of Live Action, told CNSNews.com.

“They want to protect that money,” she said. “They want to do everything they can to protect that interest. Because the majority of Americans consider themselves against taxpayer-funded abortions — more Americans consider themselves pro-life than pro-choice – they realize they are not on the side of the people, and so they have to win their political game with lies about services that Planned Parenthood does provide.”

Planned Parenthood did not respond to calls from CNSNews.com on Wednesday.

PolitiFact.com said Planned Parenthood does not provide mammograms and, in September, said that that assertions about mammogram testing in a book about Planned Parenthood, entitled Planned Bullyhood, are true.

Karen Handel, former vice president for policy at the Susan B. Komen Race for the Cure, and the author of Planned Bullyhood, had said, “the truth is, Planned Parenthood does not provide mammograms. Planned Parenthood refers women to mammography providers, serving as the middle-woman, if you will.”

PolitiFact said that was true, reporting, “We asked, and in an e-mail response, a spokeswoman for the organization said doctors and nurses at Planned Parenthood health centers provide clinical breast exams and refer patients to facilities with technicians for mammograms based on breast exams, age or family history.”

“Planned Parenthood also refers women to breast specialists when a potential abnormality is found and follow-up tests are needed,” said PolitiFact. “And with the organization’s expanded breast health initiative, Planned Parenthood will be able to cover the cost of this specialized care for more women, the email said.”

Mammograms are x-rays of the breast, which are used to help detect breast cancer.

The Q&A section on mammograms on the website includes a question, “where can I get a mammogram?” The answer, “Ask your heal care provider, health department, or staff at your local Planned Parenthood health center about where you can get a mammogram in your area.”

In February, a controversy erupted when the Susan G. Komen for the Cure decided to stop funding Planned Parenthood. One reason given in the Feb. 3 edition of The Washington Post by Komen President Nancy Brinker was, “It was nothing they were doing wrong. We have decided not to fund, wherever possible, pass-through grants. We were giving them money; they were sending women out for mammograms. What we would like to have are clinics where we can directly fund mammograms.”

Obama mentioned Planned Parenthood, the nation’s largest abortion provider, five times during Tuesday’s debate.

At other points during the debate, Obama said, “We haven’t heard from the governor any specifics beyond Big Bird and eliminating funding for Planned Parenthood in terms of how he pays for that.”

He later added, “George Bush never suggested that we eliminate funding for Planned Parenthood.”

Planned Parenthood is the largest abortion-provider in the nation. According to its own fact sheets, Planned Parenthood performed 985,731 abortions between 2008 and 2010 – 329,445 in 2010 alone. Planned Parenthood also receives taxpayer money every year and got $487.4 million in 2009-2010.

I was perusing Capitalism Magazine and came across an article written by Richard Ralston and posted about a week ago. He explains how the FDA is not allowing a stem cell procedure in which one’s own cells taken from one part of the body are used to repair cells in the other part. I remember when the left was up in arms because George Bush put a freeze on federal funding for the use of embryonic stem cells, so I’m wondering where the outrage is over this? There aren’t any ethical problems with the using one’s own stem cells, so what’s the problem.

From the article:

The Food and Drug Administration (FDA) has gone to court to prevent the Colorado-based firm Regenerative Sciences from using stem cells developed in one part of your body (bone marrow) to repair damage in other parts of your body, such as joints. The FDA objects to the fact that these cells are chemicals, the use of which they have the power to regulate even though the cells are taken from your body to later be injected back into your body.

The FDA is accustomed to the process by which it requires that many years and millions of dollars be spent to approve drugs developed in a laboratory before anyone is allowed to use them. Regardless of clinical results that show use of stem cells to be highly effective, the FDA finds it intolerable to let you use the cells in your own body without prior approval by a vast and expensive bureaucracy.

It is a shame that no one told all of those who would benefit from stem cell research that the benefits of such research would not actually be available to patients. Treatment of individuals does not comply with the FDA’s regulatory paradigm. Personalized medicine may work new miracles, but care for the individual must be subordinated to supervision by a multitude of administrators.

Growing government involvement in medicine, over generations, has resulted in control for the controller’s sake. The most extreme example of this is the refusal of the FDA, in many cases, to forbid access by terminally ill patients to drugs that have passed the first phase of testing, which establishes safety. (Read More)

Talk about stuck on stoopit! This is the natural result when we lose liberty though isn’t it? Once we cede control to government, all bets are off, and soon, all liberties are lost. For instance, were you aware that if you are on Medicare

In 2010, another hurdle was created with the passage of Obamacare. The Independent Payment Advisory Board (IPAB)–”independent” because it is appointed by the President–decides whether it will allow payment for any care, including use of your stem cells. If you are on Medicare and your physician accepts Medicare patients, you may not even use your own money for treatment with your own stem cells. No physician in Medicare is allowed to accept payment for anything not covered by Medicare.

Got that? What possible business is it of the government to tell a doctor, what treatments they may provide, or what form of legitimate payment they can accept for that treatment? What does such a stipulation have to do with curbing costs? If you pay out of pocket, Medicare obviously is not paying, so, what possible reason is there? Think on that my friends. Like I, and many others have said over and again. This is all about control!

Recently, there have been shortages of some medicines. Cancer patients can’t get drugs they need. Why not?

One reason is that a big drugmaker shut down for a year in part to meet Food and Drug Administration rules. The FDA makes it so expensive and difficult to sell drugs that there isn’t an eager pack of companies rushing to the fill the gap. The free market would provide that, but government intervention, such as low Medicare reimbursement, strangles it. So people suffer.

Does the FDA say it’s sorry for its part and back off? Of course not. Regulators almost never do that. In fact, the FDA wants more power.

It wants to regulate how your doctor uses his smartphone. I’m not kidding! The FDA wants the power to approve mobile medical apps that let doctors monitor patients’ vital signs over their phones. As one doctor put it, “Even though I’m away from the hospital, I can still look at … real-time wave form data just as if I were at the patient’s bedside.”

Sounds great. It makes doctors more efficient. But the FDA basically says, “No, you just can’t put something on your phone if it’s a medical device. What if it doesn’t work right? We have to approve it first.”

Go read it all. This is the inherent failure that any big government program or agency runs into. And then there is waste, fraud, corruption, power hungry bureaucrats, and on and on the list goes. The fact is this the farther removed from the people the power is, the worse things get!